Purpose of this Study
We are doing this study to find out if an experimental drug called PT217 (the study drug) is a safe and effective option for people who have neuroendocrine carcinomas. We want to see how this drug works when it is given on its own and in combination with standard chemotherapy and/or immunotherapy drugs.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have one of the following types of cancer: small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC)
- Have disease that is advanced (metastatic or unresectable), relapsed, first-line, or second-line
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study has 3 phases:
- Dose Expansion Phase: this part of the study will test different dose levels of the study drug to find out which specific dose(s) seem to be most effective.
- Chemo Combination Therapy Phase: this part of the study will test how the study drug works when it is combined with the typical chemotherapy regimens that are used to treat your type of cancer.
- ICI (Immune Checkpoint Inhibitors) Combination Therapy Phase: this part of the study will test how the study drug works when it is combined with the typical immunotherapy regimens that are used to treat your type of cancer.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Phanes Therapeutics / The SKYBRIDGE study, an Open-label, Multicenter, Dose Escalation and Dose Expansion Phase 1/2 Study with PT217 Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients with NeuRoendocrIne Carcinomas That Are Known to Be DLL3 ExpressinG CancErs
Principal Investigator
Laura
Alder
Protocol Number
PRO00117090
NCT ID
NCT05652686
Phase
I/II
Enrollment Status
Pending Open to Enrollment